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NCT Number: NCT06695221

Improving Health Outcomes With Kefir

The purpose of the study is to ascertain whether traditional kefir not only enhances vascular health but also contributes to improved immune outcomes in both male and female participants at higher risk or living with Type 2 Diabetes (T2D) after 12 weeks of treatment.

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Key information

Age range

24 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alberta

Edmonton, Alberta, T6G 2E1, Canada

Location status: Recruiting

Location contact

Benjamin Willing, PhD

PRINCIPAL_INVESTIGATOR

Caroline Richard, PhD

SUB_INVESTIGATOR

Laurie Mereu, Dr

SUB_INVESTIGATOR

Paulina Aldana Hernandez, PhD

CONTACT

[email protected]

780-492-9506

About this study

Participants who sign the written consent form will undergo a screening process to determine eligibility for study entry. At the baseline visit, recruited participants will be randomized in a double-blind manner (participant and study coordinator) to consume either 350 mL of traditional fermented kefir or 350 mL of a placebo (milk) daily. During the 12 weeks of intervention, health outcomes will be measured and collected for further analysis.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • females and males (24-70 years old) living in Edmonton (or Edmonton area/driving distance);
  • overweight or obesity (BMI >25 Caucasian, >23 Asian);
  • at higher risk of T2D (fasting blood glucose ≥ 5.6 - 6.9 mmol/L or/and HbA1C ≥ 5.5 - 6.4%); or
  • with diagnosis of T2D (fasting blood glucose ≥ 7.0 mmol/L or/and HbA1C ≥ 6.5%).

Exclusion criteria

  • a usual high intake (maximum intake 3 servings/week) of fermented foods excluding cheese (i.e., kefir, kombucha, kimchi, etc.) for the past 3 months;
  • gastrointestinal (GI) disorders of any kind;
  • being pregnant or breastfeeding;
  • monogenic dyslipidemias and endocrine disorders except for diabetes;
  • use of medications within the last 3 months (i.e., antibiotics or antifungals, corticosteroids, methotrexate, or immunosuppressive cytotoxic agents);
  • any health conditions deemed to interfere with primary outcomes at the investigator's discretion (e.g., kidney disease, liver disease, cancer, GI surgery, heavy alcohol consumption, etc.);
  • having a pacemaker or any electrical medical device that prevents the individual from undergoing the bioelectrical impedance analysis bioimmunoassay (BIA) test."

Treatment and study plan

Traditional Kefir

Dietary Supplement

350 mL/day of traditional fermented/prepared kefir

Milk (placebo)

Dietary Supplement

350 mL/day of commercial 2% fat milk

Primary outcomes

  1. Change in Glycated Hemoglobin (HbA1c) Levels (Percentage)

    Time frame: Baseline, 6 weeks, 12 weeks

    The primary outcome is the change in HbA1c levels, measured as a percentage of total hemoglobin using standard laboratory methods. This measurement assesses average blood glucose levels over the past 2-3 months, providing insight into the effect of our traditional kefir on long-term glucose regulation.

Secondary outcomes

  1. Change in Fasting Plasma Glucose Levels (mmol/L)

    Time frame: Baseline, 6 weeks, 12 weeks

    This outcome measures the change in fasting plasma glucose levels using standard blood glucose analysis. The assessment at multiple time points will provide insights into the short-term impact of our traditional kefir on fasting glucose regulation.

  2. Change in Total Cholesterol (mmol/L)

    Time frame: Baseline, 6 weeks, 12 weeks

    This outcome evaluates changes in total cholesterol concentration, providing insights into the effect of our traditional kefir on lipid metabolism and cardiovascular risk. It will be measured in serum samples using standard laboratory methods.

  3. Change in Low-Density Lipoprotein Cholesterol (LDL-C) (mmol/L)

    Time frame: Baseline, 6 weeks, 12 weeks

    This outcome measures the change in LDL-C levels, a primary marker of cardiovascular health, to assess the potential cardiovascular benefits of our traditional kefir. It will be measured in serum samples using standard laboratory methods.

  4. Change in High-Density Lipoprotein Cholesterol (LDL-C) (mmol/L)

    Time frame: Baseline, 6 weeks, 12 weeks

    This outcome assesses the change in HDL-C concentration to evaluate whether our traditional kefir consumption has beneficial effects on lipid profiles. It will be measured in serum samples using standard laboratory methods.

  5. Change in Triglyceride levels (mmol/L)

    Time frame: Baseline, 6 weeks, 12 weeks

    This outcome measures the change in triglyceride concentration to determine the effect of our traditional kefir on lipid metabolism and metabolic health. It will be measured in serum samples using standard laboratory methods.

  6. Change in Circulating C-Reactive Protein (CRP) Levels (mg/L)

    Time frame: Baseline, 6 weeks, 12 weeks

    This outcome measures changes in CRP, a systemic inflammation marker, providing insight into whether our traditional kefir impacts inflammatory responses in participants. It will be measured in plasma samples using standard laboratory methods.

  7. Change in Interleukin-2 (IL-2) in Supernatant of Ex Vivo Stimulated Cells from Whole Blood (pg/mL)

    Time frame: Baseline, 6 weeks, 12 weeks

    This outcome measures changes in IL-2 levels in the supernatant of ex vivo-stimulated cells derived from whole blood, serving as a surrogate marker of T-cell proliferation. IL-2 will be quantified using cytokine analysis of cell culture supernatants following mitogen stimulation. This assessment provides insight into immune function and response.

  8. Change in T Helper Cell Response Measured by Interferon-Gamma (IFN-γ) Levels in Supernatant of Ex Vivo Stimulated Cells from Whole Blood (pg/mL)

    Time frame: Baseline, 6 weeks, 12 weeks

    This outcome evaluates changes in interferon-gamma (IFN-γ) levels in the supernatant of ex vivo-stimulated cells derived from whole blood. IFN-γ is a key cytokine secreted by T helper cells, serving as an indicator of cellular immune response and Th1 activity. IFN-γ will be quantified using cytokine analysis of cell culture supernatants following mitogen stimulation.

  9. Change in Tumor Necrosis Factor-Alpha (TNF-α) Levels in Supernatant of Ex Vivo Stimulated Cells from Whole Blood (pg/mL)

    Time frame: Baseline, 6 weeks, 12 weeks

    This outcome measures changes in TNF-α levels in the supernatant of ex vivo-stimulated cells derived from whole blood. TNF-α is a pro-inflammatory cytokine and serves as a marker of immune system activation. TNF-α will be quantified using cytokine analysis of cell culture supernatants following mitogen stimulation.

  10. Change in Gut Microbiome Composition and Functional Capacity (Relative Abundance)

    Time frame: Baseline, 6 weeks, 12 weeks

    This outcome examines changes in the composition and functional capacity of the gut microbiome using 16S rRNA gene sequencing or metagenomic analysis. The analysis will focus on relative abundance and diversity of bacterial taxa and functional pathways associated with metabolic health.

Other outcomes

  1. Changes in Body Weight (Kg)

    Time frame: Baseline, 6 weeks, 12 weeks

    This outcome measures changes in body weight using a calibrated digital scale. Participants' weight will be assessed while wearing light clothing and no shoes. This measurement evaluates the effect of our traditional kefir on overall body mass.

  2. Change in Body Mass Index (BMI) (kg/m²)

    Time frame: Baseline, 6 weeks, 12 weeks

    BMI will be calculated using body weight (kg) and height (m) measurements. Height will be measured using a stadiometer at baseline only, and BMI will be monitored to assess changes in body composition.

  3. Change in Waist Circumference (cm)

    Time frame: Baseline, 6 weeks, 12 weeks

    This outcome evaluates changes in waist circumference, measured at the umbilical level using a non-elastic tape. This measurement serves as an indicator of central adiposity and fat distribution.

  4. Change in Hip Circumference (cm)

    Time frame: Baseline, 6 weeks, 12 weeks

    Hip circumference will be measured at the widest part of the hips using a non-elastic tape. This outcome helps determine changes in fat distribution and body shape.

  5. Change in Body Composition (Percentage of Fat Mass and Fat-Free Mass) Measured by Bioelectrical Impedance Analysis (BIA)

    Time frame: Baseline, 6 weeks, 12 weeks

    Body composition will be assessed using BIA to determine changes in fat mass and fat-free mass as percentages of total body weight. Participants will be measured in a fasted state with consistent hydration levels for accuracy.

Study contacts

Contact information is provided by the study sponsor or research team.

Paulina Aldana Hernandez, PhD

CONTACT

[email protected]

780-492-9506

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Nov 19, 2024
Registry last updated
May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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